Breast Cancer
Conditions
Keywords
breast cancer, dense breasts, mammography screening, Screening techniques, women
Brief summary
This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis
Interventions
digital breast tomosynthesis technology
Automated Whole Breast Ultrasound
Sponsors
GE Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures; * Women aged ≥18 years at the time of enrollment;\* * Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense; * At moderately increased or high risk (\>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1: AND Referred for screening mammography
Exclusion criteria
* Have been screened using any breast imaging technology in \<12 months immediately prior to enrollment; * Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment; * Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment; * Are currently pregnant as determined per standard clinical practice at the investigational site; * Present with contraindications to any imaging examination required in the study protocol; * Have breast implants; OR * Are lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abnormal interpretation rate | One Year | Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | One Year | Sensitivity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS |
| Specificity | One Year | Specificity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS |
| Cancer Rate | One Year | Cancer Rate will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS |
| Positive Predictive Value | One Year | Positive Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS |
| Negative Predictive Value | One Year | Negative Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS |
Countries
United States
Outcome results
None listed